Associate II, Manufacturing
About Site
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.
The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.
The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
Position Summary
We have an opportunity for an Associate II, Manufacturing to join our team. In this role, you will support GMP upstream or downstream manufacturing processes for bulk biologics from microbial and cell culture systems. You will apply your knowledge to solve operational and routine tasks for Phase I/II and commercial GMP manufacturing. This position reports to the Supervisor, Manufacturing and plays a key role in ensuring compliance and operational excellence.
Shift: Day shift, 7am-7pm on a 2-2-3 rotation
Location: Harmans, MD - BWI
100% Onsite
The Role
Complete Batch Production Records under current Good Manufacturing Practices and document processes using Standard Operating Procedures and Batch Production Records
Generate operational protocols and internal or external documents including Standard Operating Procedures, Batch Production Records, deviations, and summary reports
Collaborate with Process Development and Manufacturing Sciences and Technology teams to transfer new projects into GMP
Generate and revise internal and external documents such as Standard Operating Procedures and Batch Records
Support initiation and closure of deviations; may lead departmental investigations and close deviations and Corrective and Preventive Actions
Troubleshoot process and equipment issues; work with Facilities and Validation to maintain manufacturing equipment
Recommend equipment and supply purchases for production areas
Develop creative solutions to operational problems using knowledge of available theories and proven solutions
Work closely with production management on current and new manufacturing projects to develop processes and techniques to meet objectives and avoid delays
Collaborate with various departments and assist other teams as needed
Interact with clients during manufacturing campaigns; may oversee and escort person-in-plant during campaigns
Participate in facility expansion and equipment validation activities
Maintain full training in all GMP manufacturing operations and documentation while adhering to safety guidelines
Perform other duties as assigned
The Candidate
Minimum Requirements
High School diploma or General Education Diploma with 4+ years of experience in upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance OR Associate’s degree in a Scientific, Engineering, or Biotech field with 2+ years of experience in upstream or downstream biologic production processes under GMP compliance OR Bachelor’s degree in a Scientific, Engineering, or Biotech field with 1+ years of experience in upstream or downstream biologic production processes under GMP compliance
Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks
Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports
Team-oriented with the ability to collaborate effectively…